phase ii clinical study of intermittent high dose of icotinib in combination with docetaxel to treat lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: 1. there is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (egfr) gene wild type non-small-cell lung cancer (nsclc) . 2. icotinib is a new type of small molecule egfr tki, developed and patented by zhejiang betapharma co., ltd.(hangzhou, zhejiang, china, patent no. wo2003082830). it has the similar anti-tumor activity with gefitinib, erlotinib. pre-clinical studies showed icotinib could significantly inhibit the egfr tyrosine kinase activity. notably, anti-tumor activities were observed in patients with advanced nsclc. 3. in this study, we will evaluate the efficiency of intermittent high dose of icotinib in combination with docetaxel as second-line treatment for nsclc patients with wild type egfr. the overall response rate(orr),progression free survival(pfs) ,overall survival(os) and health related quality of life(hrqol) will be monitored.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib/iv nsclc patients progressing after first-line chemotherapy; * patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity; * age: 18-70 years old; * patients with wild-type egfr; * with a histologically or cytologically confirmed measurable disease (longest diameters \>=10mm with spiral computed tomography (ct)and \>=20mm with conventional ct) according to response evaluation criteria in solid tumors (recist criteria); * patients must have eastern cooperative oncology group(ecog)performance status of 0-2; * must have an expected survival time of at least 12 weeks; * patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (anc) of ≥1.5 ´ 109/l, platelet count of ≥ 75´ 109/l; hemoglobin(hb) ≥ 9g/dl; * adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(ast )and glutamate pyruvate transaminase(alt)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases); * adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal; * no malabsorption or other gastrointestinal disorders affecting drug absorption; * female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment; * patients have provided a signed informed consent form. exclusion criteria: * experience of anti-egfr monoclonal antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab; * concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or st. john's wort; * allergic to icotinib or any of the excipients of this product. * prior chemotherapy with any paclitaxel agents; * central nervous system (cns) metastases without radiotherapy and/or surgery; * evidence of clinically active interstitial lung diseases; * severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases; * patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ); * psychiatric illness that would prevent the patient from giving informed consent; * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study; * patient is concurrently using other approved or investigational antineoplastic agent; * pregnant or lactating women; * positive epidermal growth factor receptor mutation.

Keywords: non small cell lung cancer wild type egfr icotinib second-line treatment